Study design and protocol for tailored Acceptance and Commitment Therapy (ACT) to optimize quality of life in women living with metastatic breast cancer

Moreno, Patricia I.; Horner, Fiona S.; Torzewski, Joanna B.; Thomas, Jessica L.; Gradishar, William; Victorson, David; Penedo, Frank J.

doi:10.1016/j.conctc.2021.100870

Cited by 12Mindfulness and Compassion InterventionsCancer survivorship and carePalliative and Oncologic Care

Study design and protocol for tailored Acceptance and Commitment Therapy (ACT) to optimize quality of life in women living with metastatic breast cancer

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Moreno, Patricia I., Horner, Fiona S., Torzewski, Joanna B., Thomas, Jessica L., Gradishar, William, Victorson, David, Penedo, Frank J.·2022·Contemporary Clinical Trials Communications

DOI 10.1016/j.conctc.2021.100870PMC PMC8703025

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Abstract

Women living with metastatic (stage IV) breast cancer face unique challenges, including arduous treatments, side effects, chronic symptom burden, and emotional distress. Nevertheless, most research has paradoxically focused on optimizing quality of life in women with early-stage, non-metastatic breast cancer. Acceptance and Commitment Therapy (ACT) is an evidence-based, third-wave cognitive behavioral therapy that focuses on creating 'a life worth living' by promoting meaning and purpose and optimizing quality of life. ACT may be particularly well-suited for women with metastatic breast cancer as it addresses salient existential concerns, while allowing for the co-occurrence of feelings of grief and loss that are normal and expected when facing a life-limiting prognosis. This manuscript describes the rationale and study design of a pilot randomized controlled trial to develop and assess the feasibility and acceptability of a tailored ACT intervention for women living with metastatic breast cancer. Participants (N = 30) will be randomized 1:1 to either ACT, cognitive behavioral stress management (CBSM), or a usual care control. Both ACT and CBSM are 8-week, group-based interventions that will be delivered online. Primary outcomes are rates of acceptance, retention, and satisfaction. Preliminary effects on variables of interest, including meaning and purpose, psychological flexibility, and several domains of quality of life, will also be examined. Findings will inform the conduct of a full-scale randomized controlled trial of our tailored ACT intervention in women living with metastatic breast cancer.

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Psychological intervention in metastatic breast cancer patients is associated with improved quality of life.
“Examples of the outcomes of psychological intervention in this group are higher survival rates at ten-year follow-up, decreased depressive symptoms, and improved quality of life in individuals with metastatic breast cancer [19,20,21].”
From Psychological Intervention and Breast Cancer (2024) · cites this paper as [21]
The Introduction says stress-management interventions have improved quality of life in women with breast cancer generally. For women with metastatic breast cancer, it reports reduced fatigue and sleep-related impairment after ACT, but not an established improvement in overall quality of life. The Discussion describes quality-of-life improvement in this population as a hypothesis for the proposed trial, not a result. (LLM, conf=0.86)
Experimental — accuracy not yet measured
Focusing on psychological factors such as distress tolerance and death anxiety can effectively reduce the amount of psychological damage in patients.
“Consequently, focusing on psychological factors such as distress tolerance and death anxiety can effectively reduce the amount of psychological damage in patients (Moreno et al., 2022).”
From The Effectiveness of Acceptance and Commitment Therapy on Distress Tolerance and Death Anxiety in Patients with Lung Cancer (2023) · cites this paper as Moreno et al., 2022
The Introduction (page unavailable) says ACT may reduce distress in early-stage breast cancer survivors, and the Measures section identifies distress tolerance as a skill targeted by ACT. But this paper is a study protocol, not evidence that targeting distress tolerance and death anxiety effectively reduces psychological harm in patients; it does not report that specific outcome. (LLM, conf=0.86)
Experimental — accuracy not yet measured
Psychological intervention in metastatic breast cancer patients is associated with higher survival rates at ten-year follow-up.
“Examples of the outcomes of psychological intervention in this group are higher survival rates at ten-year follow-up, decreased depressive symptoms, and improved quality of life in individuals with metastatic breast cancer [19,20,21].”
From Psychological Intervention and Breast Cancer (2024) · cites this paper as [21]
The Introduction says survival has increased with life-prolonging and palliative treatments, not psychological intervention. The Discussion describes a planned pilot trial assessing feasibility and quality of life; our copy provides no ten-year survival finding. Searches for ten-year follow-up and survival after psychological intervention found no supporting passage. Page numbers were not available in the indexed copy. (LLM, conf=0.76)
Experimental — accuracy not yet measured
Psychological intervention in metastatic breast cancer patients is associated with decreased depressive symptoms.
“Examples of the outcomes of psychological intervention in this group are higher survival rates at ten-year follow-up, decreased depressive symptoms, and improved quality of life in individuals with metastatic breast cancer [19,20,21].”
From Psychological Intervention and Breast Cancer (2024) · cites this paper as [21]
The Introduction reports that a pilot ACT intervention in women with metastatic breast cancer decreased fatigue and sleep-related impairment, not depressive symptoms. The Measures section says depression will be assessed in the planned trial, but our copy reports no depression outcome for metastatic breast cancer patients. Searched for depressive symptoms and depression following psychological intervention. (LLM, conf=0.76)
Experimental — accuracy not yet measured

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“Furthermore, previous ACT trials in the cancer context have employed either educational controls [34–36] or usual care/no control [32,33] rather than test the effects of ACT against an existing, evidence-based intervention like cognitive behavioral stress management (CBSM).”
BackgroundMethod
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An Acceptance and Commitment Therapy (ACT) group intervention for cancer survivors experiencing anxiety at re-entry.
Arch, J. J., & Mitchell, J. L. (2016) · Psycho-Oncology · doi:10.1002/pon.3890 · Cited by 103 · cited 2× · see citing works
“Furthermore, previous ACT trials in the cancer context have employed either educational controls [34–36] or usual care/no control [32,33] rather than test the effects of ACT against an existing, evidence-based intervention like cognitive behavioral stress management (CBSM).”
BackgroundMethod
Acceptance and commitment therapy for symptom interference in advanced lung cancer and caregiver distress: a pilot randomized trial.
Mosher, C. E., Secinti, E., Hirsh, A. T., Hanna, N., Einhorn, L. H., Jalal, S. I., Durm, G., Champion, V. L., & Johns, S. A. (2019) · Journal of Pain and Symptom Management · doi:10.1016/j.jpainsymman.2019.06.021 · Cited by 98 · see citing works
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Method
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Authors: Moreno, P. I., Horner, F. S., Torzewski, J. B., Thomas, J. L., Gradishar, W., Victorson, D., & Penedo, F. J.
Affiliations: University of Miami (US)
Carnegie Mellon University (US)
Northwestern University (US)
Corresponding author: Moreno, Patricia I.
ORCID: Moreno, Patricia I.
Horner, Fiona S.
Thomas, Jessica L.
Gradishar, William
Victorson, David
Penedo, Frank J.
Venue: Contemporary Clinical Trials Communications
Publisher: Elsevier BV
Published: 2022-02
Volume: 25
Pages: 100870
ISSN: 2451-8654 (ISSN-L)
DOI: 10.1016/j.conctc.2021.100870
PMC: PMC8703025
OpenAlex: W4200205759
Cited by: 12
References: 18
Citations by year: 2026: 1 · 2025: 3 · 2024: 5 · 2023: 1 · 2022: 2
FWCI: 1.36
Type: journal article
Language: en
Open access: gold
doi.org
Licence: cc-by-nc-nd
www.elsevier.com/tdm/userlicense/1.0/ (tdm)
www.elsevier.com/legal/tdmrep-license (tdm)
creativecommons.org/licenses/by-nc-nd/4.0/ (vor)
Locations: Contemporary Clinical Trials Communications (publishedVersion, cc-by-nc-nd)
PubMed Central (publishedVersion, cc-by-nc-nd)
PubMed (publishedVersion)
DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
Funders: National Institutes of Health
American Cancer Society (IRG -18-163-24)
Topics: Social Sciences › Psychology › Clinical Psychology › Mindfulness and Compassion Interventions
Health Sciences › Medicine › Oncology › Cancer survivorship and care
Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Palliative and Oncologic Care
Keywords: acceptance and commitment therapy, metastatic breast cancer, quality of life, cognitive-behavioral stress management, psychological flexibility, meaning and purpose, existential concerns, grief and loss, online group intervention, intervention feasibility and acceptability, women with cancer

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Study design and protocol for tailored Acceptance and Commitment Therapy (ACT) to optimize quality of life in women living with metastatic breast cancer

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